Hollesta 10 mg, 20 mg and 40 mg film-coated tablets – simvastatin to lower cholesterol and protect the heart

Hollesta contains simvastatin, a medicine from the statin group (HMG-CoA reductase inhibitors) that lowers total cholesterol, “bad” LDL cholesterol and triglycerides in the blood and increases “good” HDL cholesterol. It is manufactured by Alkaloid and is authorised in Serbia in strengths of 10 mg, 20 mg and 40 mg, as film-coated tablets in packs of 30.

LDL cholesterol can build up in artery walls and form plaque that narrows blood vessels and slows blood flow to the heart and brain – this may lead to a heart attack or stroke. Hollesta is always taken together with a cholesterol-lowering diet, and in people with coronary heart disease or at high risk it reduces the risk of heart disease regardless of cholesterol levels.

What is Hollesta used for and how should it be taken?

Basic information about the medicine

What is Hollesta used for?

According to the leaflet and the Summary of Product Characteristics, Hollesta is used together with diet to lower cholesterol:

• in raised blood cholesterol (primary hypercholesterolaemia) or raised blood fats (mixed dyslipidaemia), when diet, physical activity and weight reduction are not enough
• in homozygous familial hypercholesterolaemia – an inherited disease, in addition to diet and other treatments (e.g. LDL apheresis)
• to reduce cardiovascular mortality and morbidity in patients with atherosclerotic cardiovascular disease or diabetes (because of blood vessel disease, stroke etc.), with normal or raised cholesterol, in addition to correction of other risk factors

High cholesterol usually causes no symptoms – levels are checked with a simple blood test, and target values should be agreed with your doctor.

How is it taken and dosed?

The tablet is taken once a day in the evening, with or without food. Your doctor chooses the strength according to your condition, other treatment and risk.

• The dose may be adjusted at intervals of at least 4 weeks, up to a maximum of 80 mg daily (80 mg only in severe hypercholesterolaemia and high risk when lower doses are not enough). Do not take more than 80 mg a day.
• With fibrates (other than gemfibrozil, which is contraindicated, and fenofibrate): maximum 10 mg daily. With amiodarone, amlodipine, verapamil, diltiazem or medicines containing elbasvir/grazoprevir: maximum 20 mg daily. With lomitapide: maximum 40 mg daily.
• If you also take a bile acid sequestrant (a cholesterol medicine), take Hollesta at least 2 hours before or 4 hours after it.
• Continue treatment until your doctor tells you to stop, and stay on a cholesterol-lowering diet during treatment.

This is the general dosing from the leaflet – your doctor decides your dose.

Special patient groups

• Children and adolescents: studied in boys aged 10 to 17 and girls at least one year after their first period; not studied in children under 10.
• Elderly: no dose adjustment is needed, but people aged 65 and over have a higher risk of muscle damage.
• Kidney impairment: no dose change in moderate impairment; in severe impairment (creatinine clearance below 30 mL/min) doses above 10 mg daily are used only with great caution.
• Liver impairment: the medicine must not be taken in current liver problems; if you have had liver disease, it may not be the right medicine for you.

Contraindications – when the medicine must not be used

• allergy to simvastatin or any of the excipients
• current liver problems
• pregnancy and breastfeeding
• concomitant use of: itraconazole, ketoconazole, posaconazole or voriconazole; erythromycin, clarithromycin or telithromycin; HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir); boceprevir or telaprevir; nefazodone; cobicistat; gemfibrozil; ciclosporin; danazol
• fusidic acid given by mouth or injection, now or in the last 7 days (risk of rhabdomyolysis)
• doses above 40 mg with lomitapide

Precautions and warnings

• Tell your doctor if you drink large amounts of alcohol, have had liver disease, have severe lung disease, are due to have planned surgery (treatment may be paused) or are of Asian origin.
• Your doctor will check your liver function with blood tests before starting treatment and, if needed, during it.
• The risk of muscle damage is higher with higher doses (especially 80 mg), in people aged 65 and over, women, people with kidney or thyroid problems, those who previously had muscle problems with statins or fibrates, in inherited muscle disorders and with heavy alcohol use.
• If you have diabetes or are at risk of it (high blood sugar and fats, obesity, high blood pressure), your doctor will monitor you closely.
• Also tell your doctor if you have constant muscle weakness – additional tests may be needed.
• The medicine contains lactose monohydrate – if you have an intolerance to some sugars, talk to your doctor.

Interactions with other medicines, food and drink

In addition to the medicines listed under contraindications, the risk of muscle problems is also increased by:

• fluconazole, bezafibrate and other fibrates, amiodarone, verapamil, diltiazem, amlodipine, lomitapide, colchicine, ticagrelor
• hepatitis C medicines (elbasvir, grazoprevir) and daptomycin (your doctor may pause Hollesta)
• oral fusidic acid – Hollesta is temporarily stopped until your doctor says it is safe to restart

Also be sure to tell your doctor if you take anticoagulants (warfarin, phenprocoumon, acenocoumarol), fenofibrate, niacin or rifampicin. Tell any doctor prescribing another medicine that you are taking Hollesta.

Food and drink: grapefruit juice changes the metabolism of simvastatin and should be avoided. Food does not affect absorption of the medicine.

Pregnancy and breastfeeding

Do not take Hollesta if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant during treatment, stop taking the medicine immediately and contact your doctor. Do not take it while breastfeeding, as it is not known whether it passes into breast milk.

Driving and using machines

Hollesta is not expected to affect your ability to drive or use machines, but some people may experience dizziness – keep this in mind.

Possible side effects

Rare serious side effects – stop taking the medicine and contact your doctor or emergency department immediately:

• muscle pain, tenderness, weakness, rupture or cramps; muscle damage can rarely be serious, with kidney damage, very rarely fatal
• hypersensitivity reactions: swelling of the face, tongue and throat with difficulty breathing (angioedema), severe pain in the shoulder and hip muscles, joint pain or inflammation, inflammation of blood vessels, unusual bruising, rash and swelling, hives, skin sensitivity to sunlight, fever, flushing, shortness of breath, lupus-like symptoms
• liver inflammation (yellowing of the skin and eyes, itching, dark urine or pale stools, tiredness, loss of appetite) and very rarely liver failure
• inflammation of the pancreas with severe abdominal pain

Very rare: anaphylaxis, lichenoid skin rash or mouth sores, muscle rupture, gynaecomastia. Rare: anaemia, numbness or weakness in arms and legs, headache, tingling, dizziness, blurred or impaired vision, abdominal pain, constipation, indigestion, bloating, diarrhoea, nausea, vomiting, rash, itching, hair loss, weakness, sleep and memory problems (very rare), confusion. Frequency not known: erectile dysfunction, depression, lung inflammation with persistent cough and shortness of breath, tendon problems and constant muscle weakness. With some statins diabetes in predisposed people, nightmares and sexual dysfunction have also been described; blood tests may show raised liver enzymes and creatine kinase.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: if you take more than prescribed, tell your doctor or pharmacist immediately.
• Missed dose: do not take a double dose; continue with your usual schedule the next day.
• Stopping treatment: if you stop taking the medicine, your cholesterol may rise again – your doctor decides when to stop.

Related information

For additional support in caring for your heart and blood vessels, see also the category Coenzyme Q10 products – products in this category do not replace the medicine prescribed for you.

Composition, packaging and manufacturer

• Active substance: simvastatin 10 mg, 20 mg or 40 mg per film-coated tablet.
• Excipients – core: microcrystalline cellulose; lactose monohydrate; citric acid monohydrate; ascorbic acid; butylhydroxytoluene; magnesium stearate; pregelatinised starch; povidone. Film coat (Opadry pink II 85F 24544): partially hydrolysed polyvinyl alcohol; polyethylene glycol; titanium dioxide (E171); talc; yellow and red iron oxide (E172).
• Pack: PVC/PVDC-Al blisters; 10 mg and 20 mg – 3 blisters of 10 tablets, 40 mg – 2 blisters of 15 tablets (30 film-coated tablets in total).
• Marketing authorisation holder: Alkaloid d.o.o. Beograd, Prahovska 3, Belgrade. Manufacturers: Alkaloid d.o.o. Beograd (manufacturing site Pančevački put 38, Belgrade) and Alkaloid AD Skopje, Republic of North Macedonia.

Storage

• Store below 25 °C.
• Do not use after the expiry date stated on the pack.
• Keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Why is Hollesta taken in the evening?

The leaflet states that the medicine is taken once a day in the evening, with or without food. Taking it at the same time every day makes regular treatment easier.

Can I drink grapefruit juice with Hollesta?

No – grapefruit juice contains components that change the metabolism of simvastatin, so it should be avoided during treatment.

Can a Hollesta tablet be divided?

Yes. Tablets of all strengths have a score line and can be divided into equal doses, if your doctor has prescribed it that way.

What should I do if my muscles ache during treatment?

Report unexplained muscle pain, tenderness or weakness to your doctor immediately. In rare cases statins can cause serious muscle damage, and your doctor will decide on further treatment and any tests.

Sources

• ALIMS – Summary of Product Characteristics, HOLLESTA®, 10 mg, film-coated tablets (SmPC, Serbian)
• ALIMS – Package leaflet, HOLLESTA®, 10 mg, 20 mg and 40 mg, film-coated tablets (PIL, Serbian; 10 mg authorisation)
• ALIMS – Package leaflet, HOLLESTA® (20 mg authorisation, Serbian)
• ALIMS – Package leaflet, HOLLESTA® (40 mg authorisation, Serbian)

Sources checked on: 25 October 2026.